Singapore · Health Sciences Authority · New drugs
Review target
180 working days
performance goal
Legal time limit
-
Not published
Steps
6
12 requirements
Application fee
SGD 11,600
Fee list updated 4 September 2026
For a new medicine already approved by at least one drug regulatory agency. The agency reviews full quality data but only overviews and pivotal reports for the clinical part. Quality and directions for use must match the approval. The target is 50 working days for screening and 180 working days for evaluation, without the applicant's answer time. A new chemical or biological medicine, including a vaccine, that at least one drug regulatory agency has approved.
The official review target is 180 working days (performance goal). Time the applicant takes to answer questions (clock stops) is not counted. Targets are not actual review times.
The evaluation fee, nda-1 or nda-2, abridged route is SGD 11,600 for Fee list updated 4 September 2026.
1. Online application and dossier; 2. Screening (50 days); 3. Screening questions (clock stopped); 4. Evaluation (180 days); 5. Evaluation questions (clock stopped); 6. Regulatory decision.
Outcome: Registration in the Register of Therapeutic Products. The registration is kept by paying a yearly retention fee.
Legal basis: Health Products Act 2007; Health Products (Therapeutic Products) Regulations 2016
Each box is one step; arrows show the order. Dashed boxes happen only in some cases; the orange arrows go back (for example after questions).
About 230 days end to end with the official step targets, of which up to 20 days are clock stops (time the applicant uses to answer). Targets, not actual times.
In order, with the official target for each step
What the applicant must provide or meet
Targets, not actual review times
| Longest clock stopofficial guidance. Time allowed to answer each screening question. | 20 working days |
| Validationperformance goal. Screening target. Time spent waiting for the applicant's answers is not counted. | 50 working days |
| First review cycleperformance goal. Working days from acceptance to the first set of evaluation questions. | 120 working days |
| Review targetperformance goal. Evaluation target from acceptance to decision, without the applicant's answer time. These are official targets, not actual review times. | 180 working days |
Official amounts in the local currency
| Fee | Amount |
|---|---|
| Evaluation fee, NDA-1 or NDA-2, abridged routeApplication · Fee list updated 4 September 2026 | SGD 11,600 |
| Evaluation fee, NDA-3 (further strength), abridged routeApplication · Fee list updated 4 September 2026 | SGD 6,030 |
| Screening fee, new drug application, abridged routeApplication · Fee list updated 4 September 2026 | SGD 610 |
Other routes in Singapore: New drug application, full evaluation, New drug application, verification evaluation, New drug application for a registered active ingredient (NDA-2), Standard essential medicine application, Priority review, Project Orbis (cancer medicines), Access Consortium work sharing, Special access for an unregistered medicine (named patient). See all routes on the Singapore page or explore them in the Regulatory section.
Not legal or regulatory advice. Check the current official rules before you act. This summary was checked against the official laws, regulations and regulator guidance on October 3, 2026 (29 facts checked). Parts of the approvals data are official open data reused under open licences. Data sources.